FSP Assistant, CRA

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Conduct remote tasks on designated projects in collaboration with the CRA and Clinical Lead for the study.

• Assist in site readiness and the logistical elements of the monitoring process.

• Aid in site management and remote monitoring in line with SOPs and regulatory standards.

• Execute study and site management duties as outlined in the task matrix.

• Complete and record study-specific training while familiarizing yourself with study-specific systems.

• Offer in-house assistance during pre-study evaluations and assessment waivers.

• Tailor site ICFs with relevant site contact information as necessary.

• Conduct remote evaluations of EMR/EHR checklists and support relevant assessments.

• Confirm document collection and RCR submission status; update site EDL and validate site details.

• Review materials directed at patients and their translations.

• Assist with vendor-related qualification procedures and access for site staff systems.

• Follow up on site staff training and manage logistics for IM attendance.

• Maintain vendor trackers and oversee study/site supply management.

• Facilitate the collection, review, and updating of essential documents in systems.

• Follow up on absent vendor data, such as ECGs, lab samples, and e-diaries.

• Support continuous remote evaluation of centralized monitoring tools.

• Assist with site payment processes, system updates, reconciliations, and invoice tracking.

• Carry out reconciliation tasks relating to CRF and query statuses, deviations, SAEs, and safety reports.

• Verify the status of document collection and drive actions for any missing, incomplete, or expired documents.

• Perform additional assigned site management responsibilities and client-requested FSP role activities.

• Complete administrative duties including expense reports and timesheets.

⛳️ Requirements

• Bachelor's degree in a life science field or a related discipline, or Registered Nursing certification, or equivalent relevant academic or vocational qualifications.

• Prior experience providing the necessary knowledge, skills, and abilities for the role, typically ranging from 0–2 years.

• Equivalent qualifications through a combination of suitable education, training, and directly related experience may be considered.

• Previous involvement in supporting oncology studies is preferred.

• Basic understanding of medical and therapeutic areas as well as medical terminology.

• Capacity to acquire and maintain a working knowledge of ICH GCP, relevant regulations, and company procedural documentation.

• Strong oral and written communication capabilities.

• Exceptional interpersonal and customer service abilities.

• Good organizational and time management skills with a keen attention to detail.

• Proficiency in handling multiple tasks efficiently and effectively.

• Flexibility and adaptability to changing environments.

• Ability to work both collaboratively in a team and independently.

• Well-honed critical thinking, root cause analysis, and problem-solving skills.

• Proficient computer skills with a solid understanding of MS Office.

• Ability to learn and utilize appropriate software and leverage modern technology.

• Capability to extract relevant information from study documents, electronic study data systems, CTMS, and dashboards.

• Strong English language proficiency and grammar skills.

🏝️ Benefits

• Fully remote work.

• Standard Monday–Friday work schedule.

• Home office environment.

• Equal opportunity employment.

• Reasonable accommodations for individuals with disabilities.